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Kudo, Masatoshi,Finn, Richard S,Qin, Shukui,Han, Kwang-Hyub,Ikeda, Kenji,Piscaglia, Fabio,Baron, Ari,Park, Joong-Won,Han, Guohong,Jassem, Jacek,Blanc, Jean Frederic,Vogel, Arndt,Komov, Dmitry,Evans, T Elsevier 2018 The Lancet Vol.391 No.10126
<P><B>Summary</B></P> <P><B>Background</B></P> <P>In a phase 2 trial, lenvatinib, an inhibitor of VEGF receptors 1–3, FGF receptors 1–4, PDGF receptor α, RET, and KIT, showed activity in hepatocellular carcinoma. We aimed to compare overall survival in patients treated with lenvatinib versus sorafenib as a first-line treatment for unresectable hepatocellular carcinoma.</P> <P><B>Methods</B></P> <P>This was an open-label, phase 3, multicentre, non-inferiority trial that recruited patients with unresectable hepatocellular carcinoma, who had not received treatment for advanced disease, at 154 sites in 20 countries throughout the Asia-Pacific, European, and North American regions. Patients were randomly assigned (1:1) via an interactive voice–web response system—with region; macroscopic portal vein invasion, extrahepatic spread, or both; Eastern Cooperative Oncology Group performance status; and bodyweight as stratification factors—to receive oral lenvatinib (12 mg/day for bodyweight ≥60 kg or 8 mg/day for bodyweight <60 kg) or sorafenib 400 mg twice-daily in 28-day cycles. The primary endpoint was overall survival, measured from the date of randomisation until the date of death from any cause. The efficacy analysis followed the intention-to-treat principle, and only patients who received treatment were included in the safety analysis. The non-inferiority margin was set at 1·08. The trial is registered with ClinicalTrials.gov, number NCT01761266.</P> <P><B>Findings</B></P> <P>Between March 1, 2013 and July 30, 2015, 1492 patients were recruited. 954 eligible patients were randomly assigned to lenvatinib (n=478) or sorafenib (n=476). Median survival time for lenvatinib of 13·6 months (95% CI 12·1–14·9) was non-inferior to sorafenib (12·3 months, 10·4–13·9; hazard ratio 0·92, 95% CI 0·79–1·06), meeting criteria for non-inferiority. The most common any-grade adverse events were hypertension (201 [42%]), diarrhoea (184 [39%]), decreased appetite (162 [34%]), and decreased weight (147 [31%]) for lenvatinib, and palmar-plantar erythrodysaesthesia (249 [52%]), diarrhoea (220 [46%]), hypertension (144 [30%]), and decreased appetite (127 [27%]) for sorafenib.</P> <P><B>Interpretation</B></P> <P>Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. The safety and tolerability profiles of lenvatinib were consistent with those previously observed.</P> <P><B>Funding</B></P> <P>Eisai Inc.</P>
Kudo, Masatoshi,Kang, Yoon-Koo,Park, Joong-Won,Qin, Shukui,Inaba, Yoshitaka,Assenat, Eric,Umeyama, Yoshiko,Lechuga, Maria José,Valota, Olga,Fujii, Yosuke,Martini, Jean-Francois,Williams, J. Andr S. Karger AG 2018 Liver cancer Vol.7 No.2
<P><B><I>Background:</I></B> An unmet need exists for treatment of patients with advanced hepatocellular carcinoma (HCC) who progress on or are intolerant to sorafenib. A global randomized phase II trial (ClinicalTrial.gov No. NCT01210495) of axitinib, a vascular endothelial growth factor receptor 1-3 inhibitor, in combination with best supportive care (BSC) did not prolong overall survival (OS) over placebo/BSC, but showed improved progression-free survival in some patients. Subgroup analyses were conducted to identify potential predictive/prognostic factors. <B><I>Methods:</I></B> The data from this phase II study were analyzed for the efficacy and safety of axitinib/BSC in patients from Asia versus non-Asia versus Asian subgroups (Japan, Korea, or mainland China/Hong Kong/Taiwan) and predictive/prognostic values of baseline microRNAs and serum soluble proteins, using the Cox proportional hazards model. <B><I>Results:</I></B> Of 202 patients, 78 were from non-Asia and 124 from Asia (37 Japanese, 36 Korean, and 51 Chinese). No significant differences in OS were found between axitinib/BSC and placebo/BSC in non-Asians, Asians, or Asian subgroups. However, in an exploratory analysis, axitinib/BSC showed favorable OS in Asians, especially Japanese, when patients intolerant to prior antiangiogenic therapy were excluded from the data set. Axitinib/BSC was well tolerated by non-Asians and Asians alike. The presence of 4 circulating microRNAs, including miR-5684 and miR-1224-5p, or a level lower than or equal to the median protein level of stromal cell-derived factor 1 at baseline was significantly associated with longer OS in axitinib/BSC-treated Asians or non-Asians. <B><I>Conclusions:</I></B> Axitinib/BSC did not prolong survival over placebo/BSC in non-Asians, Asians, or Asian subgroups, but favorable OS with axitinib/BSC was observed in a subset of Japanese patients. A patient population that excludes sorafenib-intolerant patients might potentially be more suitable for clinical trials of new agents in advanced HCC. Since these results are very preliminary, further investigation is warranted. The potential predictive/prognostic value of several baseline microRNAs and soluble proteins identified in this study would require validation in prospective studies on a large cohort of patients.</P>
Artificial intelligence models for the diagnosis and management of liver diseases
Naoshi Nishida,Kudo Masatoshi 대한초음파의학회 2023 ULTRASONOGRAPHY Vol.42 No.1
With the development of more advanced methods for the diagnosis and treatment of diseases, the data required for medical care are becoming complex, and misinterpretation of information due to human error may result in serious consequences. Human error can be avoided with the support of artificial intelligence (AI). AI models trained with various medical data for diagnosis and management of liver diseases have been applied to hepatitis, fatty liver disease, liver cirrhosis, and liver cancer. Some of these models have been reported to outperform human experts in terms of performance, indicating their potential for supporting clinical practice given their high-speed output. This paper summarizes the recent advances in AI for liver disease and introduces the AI-aided diagnosis of liver tumors using B-mode ultrasonography.
Takenaka Mamoru,Kudo Masatoshi 거트앤리버 소화기연관학회협의회 2022 Gut and Liver Vol.16 No.4
Drainage therapy for malignant biliary obstruction (MBO) includes trans-papillary endoscopic retrograde biliary drainage (ERBD), percutaneous transhepatic biliary drainage (PTBD), and transgastrointestinal endoscopic ultrasound-guided biliary drainage (EUS-BD). With the development of chemotherapy, many MBO cases end up needing endoscopic reintervention (E-RI) for recurrent biliary obstruction. To achieve a successful E-RI, it is necessary to understand the various findings regarding E-RI in MBO cases reported to date. Therefore, in this review, we focus on E-RI for ERBD of distal MBO, ERBD of hilar MBO, and EUS-BD. To plan an appropriate E-RI strategy for biliary stent occlusion for MBO, the following must be considered on a case-by-case basis: the urgency of the drainage, the cause of the occlusion, the original route of drainage (PTBD/ERBD/EUS-BD), the initial stent used (plastic stent or self-expandable metallic stent), and in the case of self-expandable metallic stents, the type used (fully covered or uncovered). Regardless of the original method of stent placement, if the inflammation caused by obstructive cholangitis is severe and/or the patient is in shock, PTBD should be considered as the first choice. Finally, it is important to keep in mind that in many cases, performing E-RI will be difficult.
Mamoru Takenaka,Masatoshi Kudo 대한소화기내시경학회 2022 Clinical Endoscopy Vol.55 No.5
The double-guidewire method has been increasingly used in endoscopic procedures for biliary and pancreatic diseases in recent years, including endoscopic retrograde cholangiopancreatography and endoscopic ultrasonography-related procedures. In addition, dou- ble-lumen catheters with uneven distal and proximal lumen openings have been introduced, making it possible to easily create a dou- ble-guidewire situation, and the usefulness of the double-guidewire technique using uneven double-lumen cannulas has been widely reported. Although the advantages of using two guidewires depend on the particular situation and the appropriate use of the two guidewires, deepening the knowledge of the double-guidewire method will contribute greatly to troubleshooting in daily practice. In this review, the usefulness of the double-guidewire technique is discussed with respect to two main areas: selective insertion of guide- wires and devices and biliary cannulation.